NCT01128478CompletedPhase 2
Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial
University of Auckland, New Zealand1 site in 1 country35 target enrollmentStarted: May 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Length of hospital stay
Study Overview
Brief Summary
Pain relapse during oral refeeding occurs in at least one-fifth of patients with acute pancreatitis. The study hypothesis is that early administered enteral tube feeding might reduce a risk of pain relapse and shorten the length of hospital stay in patients with acute pancreatitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of acute pancreatitis
- •age 18 years or older
- •written informed consent
Exclusion Criteria
- •> 96 hours after onset of symptoms
- •> 24 hours after hospital admission
- •organ failure by the time of randomization
- •infectious complications before randomization
- •received artificial nutrition before randomization
- •previously enrolled into the trial
- •chronic pancreatitis
- •post-ERCP pancreatitis
- •intraoperative diagnosis of acute pancreatitis
- •pregnancy
- •malignancy
Outcomes
Primary Outcomes
Length of hospital stay
Time Frame: Up to 3 months
Secondary Outcomes
- Mortality(Up to 6 months)
- Hospital readmission(Up to 6 months)
- Quality of life(Up to 6 months)
- Pain relapse(Up to 3 months)
- Local and systemic complications(Up to 3 months)
- Feeding intolerance(Up to 3 months)
- Time to solid oral food tolerated(Approx. one week)
- Pain-free time(Up to 3 months)
Investigators
Max Petrov
Principal Investigator
University of Auckland, New Zealand
Study Sites (1)
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